Principal Investigator: Jennifer Majersik
Keywords: Stroke , Memantine , Motor Recovery , Rehabilitation Department: Neurology
IRB Number: 00068751 Co Investigator: Kevin Brennan
Specialty: Occupational Therapy, Physical Medicine and Rehabilitation, Neurology
Sub Specialties: Stroke , Stroke
Recruitment Status: Recruiting

Contact Information

Michael  Dela Cruz
mike.delacruz@hsc.utah.edu
8015814258

Simple Summary

This will be a randomized double blind placebo-controlled pilot study using a repeated measures design in which participants with acute ischemic stroke and upper extremity weakness are randomized to either drug or placebo, complete therapy, and complete outcomes assessments at baseline, 4, and 12 weeks post-stroke. The primary purpose of this pilot study is to measure adverse events, drop-out rates, feasibility of trial conductance, and establishment of effect sizes in each group in order to power a larger efficacy trial at the University of Utah. MRI eligible and volunteering participants will complete one MRI scan prior to starting study therapy, a second at one month follow-up and a third at three months after starting the study drug.

Inclusion Criteria

  1. Age 18 and older
  2. Randomization between 3 days to 8 weeks of stroke symptom onset
  3. Arm weakness severe enough to warrant inpatient or outpatient occupational therapies
  4. Able to voluntarily move the affected UE
  5. Living independently prior to their stroke
  6. Image-confirmed stroke (MRI or CT)
  7. Supratentorial location of stroke
  8. Fugl-Meyer Upper Extremity Score of 50 or less and/or a Fugl-Meyer Lower Extremity Score of 28 or less
  9. Ability to swallow pills

Exclusion Criteria

  1. Subarachnoid hemorrhage, subdural hemorrhage, or other cause of symptoms other than ischemic or hemorrhagic stroke
  2. Infratentorial location of stroke (brainstem or cerebellum)
  3. NIH Stroke Scale >20 at the time of randomization
  4. History of dementia that will interfere with rehab
  5. Pre or post-stroke use of memantine or amantadine
  6. Contraindications to taking memantine XR in pill form
  7. History of prior clinical stroke with residual symptoms on the same side as the current symptoms that would interfere with outcomes of this study
  8. Documented severe renal impairment (CrCl < 30 ml/min) Blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment if not done as part of clinical care.
  9. Moribound or not expected to live 6 months
  10. Severe cognitive deficits or pre-morbid function causing inaccurate neurologic assessment or inability to complete the initial assessment
  11. Comorbid neurologic disease expected to interfere with the results. This could include diseases such as Multiple Sclerosis, neurodegenerative diseases, spinal cord disease, and CNS cancer, at the judgement of the PI.
  12. Documented severe hepatic impairment (Child-Pugh score > 6) or severe hepatic disease (hepatitis)
  13. Patients who are pregnant or breast feeding

Participant Reimbursement

$95 at the completion of the study